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The German ISSHL guideline recommends high-dose steroids without evidence from randomized controlled trials (RCTs) and refers solely to retrospective cohort studies. This RCT aims to assess the efficacy (improvement in hearing) and safety (especially systemic side effects) of high-dose steroids versus standard of care (standard dose systemic steroids) for the treatment of unilateral ISSHL, when given as a\u00a0primary therapy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The study is designed as a\u00a0multicenter (approximately 40\u00a0centers), randomized, triple-blind, three-armed, parallel group, clinical trial with 312 adult patients. The interventions consist of 5\u00a0days of 250\u202fmg\/day intravenous prednisolone (intervention\u00a01)\u202f+\u2009oral placebo, or 5\u00a0days of 40\u202fmg\/day oral dexamethasone (intervention\u00a02)\u202f+\u2009intravenous placebo. The control intervention consists of 60\u202fmg oral prednisolone for 5\u00a0days followed by five tapering doses\u202f+\u2009intravenous placebo. The primary efficacy endpoint is the change in hearing threshold in the three most affected contiguous frequencies between 0.25 and 8\u202fkHz 1\u00a0month after ISSHL. Secondary endpoints include further measures of hearing improvement including speech audiometry, tinnitus, quality of life, blood pressure, and altered glucose tolerance.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>There is an unmet medical need for an effective medical therapy of ISSHL. Although sensorineural hearing impairment can be partially compensated by hearing aids or cochlear implants (CI), generic hearing is better than using hearing aids or CIs. Since adverse effects of a\u00a0short course of high-dose systemic corticosteroids have not been documented with good evidence, the trial will improve knowledge on possible side effects in the different treatment arms with a\u00a0focus on hyperglycemia and hypertension.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) Nr.\u00a02015-002602-36; Sponsor code: KKSH-127.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00106-022-01184-8","type":"journal-article","created":{"date-parts":[[2022,6,20]],"date-time":"2022-06-20T12:03:12Z","timestamp":1655726592000},"page":"30-44","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy and safety of systemic, high-dose glucocorticoid  therapy for idiopathic sudden sensorineural hearing loss","Wirksamkeit und Sicherheit der systemischen   Hochdosis-Glukokortikoidtherapie beim akuten idiopathischen sensorineuralen H\u00f6rverlust  (H\u00f6rsturz)"],"prefix":"10.1007","volume":"70","author":[{"given":"Stefan K.","family":"Plontke","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Girndt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Meisner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"B\u00f6selt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatrice","family":"Ludwig-Kraus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Richter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torsten","family":"Rahne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,6,20]]},"reference":[{"key":"1184_CR1","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1001\/archotol.127.3.253","volume":"127","author":"C Alexiou","year":"2001","unstructured":"Alexiou\u00a0C, Arnold\u00a0W, Fauser\u00a0C et\u00a0al (2001) Sudden sensorineural hearing loss: Does application of glucocorticoids make sense? 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